补肾强骨法治疗系统性红斑狼疮患者激素性骨质疏松症临床观察

Clinical Observation of Therapy of Tonifying Kidney and Strengthening Bone for Treatment of Glucocorticoid-induced Osteoporosis in Systemic Lupus Erythematosus

【目的】观察补肾强骨法治疗系统性红斑狼疮患者激素性骨质疏松症(GIOP)的有效性及安全性。【方法】将42例系统性红斑狼疮合并GIOP患者随机分为治疗组22和对照组20例。2组均给予常规西医治疗(包括继续给予一定剂量的激素以控制系统性红斑狼疮综合症,以及口服碳酸钙D3片、骨化三醇胶囊等),治疗组在西医治疗基础上,加用本院制剂补肾强身丸(由熟地黄、肉苁蓉、巴戟天、山茱萸、枸杞子、淫羊藿、女贞子、补骨脂、黄芪、党参、山药、杜仲、桑寄生、当归、川芎、丹参、白芍等组成)。2组均以3个月为1个疗程。1个疗程后观察2组临床疗效,比较2组治疗前后的腰椎和双髋关节骨密度,中医证候积分,有关骨代谢生化指标血钙、血磷和血清碱性磷酸酶水平的变化情况及不良反应。【结果】(1)治疗3个月后,治疗组的中医证候疗效显著优于对照组(P<0.01)。(2)治疗后,2组的各项中医证候评分及总积分均较治疗前显著降低(均P<0.05);治疗后2组比较,治疗组的主症腰脊疼痛、腰膝酸软及次症脊背叩痛、眩晕耳鸣等证候评分及总积分均较对照组显著下降(均P<0.05)。(3)治疗后,治疗组3个部位的骨密度值无显著改变(均P>0.05),而对照组3个部位的骨密度值均较治疗前显著下降(P<0.05)。治疗后2组比较,对照组3个部位的骨密度值均显著低于治疗组(P<0.05)。(4)有关骨代谢生化指标方面,治疗后治疗组的血钙、血清碱性磷酸酶水平有降低趋势(P>0.05),而对照组则显著升高(P<0.05),治疗后2组比较,治疗组血钙、血清碱性磷酸酶水平显著低于对照组(P<0.05)。(5)用药期间,2组患者均未出现明显不良反应。【结论】补肾强骨法可显著改善系统性红斑狼疮患者使用糖皮质激素所导致的骨质疏松症。

Objective To investigate the clinical efficacy and safety of therapy of tonifying kidney and strengthening bone for the treatment of glucocorticoid-induced osteoporosis （GIOP） in systemic lupus erythematosus （SLE） patients. Methods Forty-two SLE-GIOP patients were randomized into treatment group （N=22） and control group （N=20） . Both groups were given conventional western medicine including glucoeorticoid, calcium carbonate D3 tablets and Calcitriol capsules. The treatment group was additionally given Bushen Qiangshen pills （mainly composed of Radix Rehmanniae Preparata, Herba Cistanches, Radix Morindae Offieinalis, Fructus Corni, Fructus Lycii, Herba Epimedii, Fructus Ligustri Lucidi, Fructus Psoraleae, Radix Astragali, Radix Codonopsis, Rhizoma Dioscoreae, Cortex Eucommiae, Herba Taxilli, Radix Angelieae Sinensis, Rhizoma Chuanxiong, Radix Salviae Mihiorrhizae, and Radix Paeoniae Alba） manufactured by our hospital. Three months constituted one treatment course, and the therapeutic effect was e valuated after one treatment course. Before and after treatment, bone mass density （BMD） of lumbar vertebra and bilateral hip joints, traditional Chinese medical syndrome scores, bone metabolism biochemical indicators including blood calcium, blood phosphor and serum alkaline phosphatase were observed. Moreover, the adverse reaction was monitored. Results （1） After treatment for 3 months, effect on improving traditional Chinese medical syndrome scores in the treatment group was superior to that in the control group （P〈0.01）. （2） Total scores of traditional Chinese medical syndrome and scores of each symptom were decreased in both groups （P〈0.05 compared with those before treatment）. Treatment group had better effect on decreasing scores of primary symptoms of lumbar pain, sore and limp loins and knees, and secondary symptoms of percussion pain in the back, vertigao and tinnitus, as well as on decreasing the total scores （P〈0.05 compared with those in the control group）. （3） BMD of lumbar vertebra and bilateral hip joints remained steady in the treatment group after treatment （P〉0.05 compared with those before treatment）, but were decreased in the control group （P〈0.05）. BMD was much lower in the control group than that in the treatment group after treatment （P〈0.05）. （4） As for the bone metabolism biochemical indicators, blood calcium and serum alkaline phosphatase showed a decreasing trend in the treatment group after treatment （P〉0.05）, but were markedly increased in the control group （P〈0.05）. Blood calcium and serum alkaline phosphatase were lower in the treatment group than those in the control group after treatment （P〈0.05）. （5） During the treatment, no obvious adverse effect was found in both groups. Conclusion Therapy of tonifying kidney and strengthening bone shows certain effect on relieving GIOP in SLE patients.